|
Product Name: Anastrozole
CAS No.: 120511-73-1
Anastrozole
CAS No.: 120511-73-1
Anastrozole
CAS No.: 120511-73-1
Application: Treat advanced breast cancer in postmenopausal women.
|
Items
|
Specification
|
Results
|
|
Characteristics
|
White crystalline powder
|
Conforms
|
|
Solubility
|
Very soluble in acetonitrile,freely soluble in water, methanol
|
Conforms
|
|
Melting point
|
81~85℃(Dried at 45℃ under vacuum)
|
82~83℃
|
|
Identification
|
IR spectrum
|
Conforms
|
|
Related substances
|
|
|
|
Any single impurities
|
≤0.5%
|
Conforms
|
|
Total impurities
|
≤1.0%
|
Conforms
|
|
Loss on drying(%)
|
≤0.5%
|
0.23%
|
|
Sulphated ash(%)
|
≤0.1%
|
0.05%
|
|
Heavy Metals
|
≤0.001%
|
Conforms
|
|
Assay(HPLC)
|
98.5%min
|
99.1%
|
|
Microbiological Items
|
|
|
|
Total Plate Count
|
1000 cfu/g
|
Conforms
|
|
Yeast & Mold
|
100 cfu/g
|
Conforms
|
|
E. coli
|
Negative
|
Conforms
|
|
Salmonella
|
Negative
|
Conforms
|
|